The present invention relates to medical devices, methods and systems for introducing fluids into and collecting a composition from a duct within a mammalian breast. More particularly, the present invention relates to medical devices, methods and systems for accessing the duct within the breast, introducing fluid within the duct, retrieving a composition from within the duct and passing the composition out of the breast so that it can be collected and analyzed without injuring the ducts within the breast or any other part of the breast.
Breast cancer is the most common cancer in women, with well over 100,000 new cases being diagnosed each year in the United States alone. Breast cancer usually begins in the cells lining a breast duct (epithelial lining), with the first stage of the cancer thought to include the excessive proliferation of individual cell(s) that lead to xe2x80x9cductal hyperplasia.xe2x80x9d Some of the hyperplastic cells may then become atypical, with a significant risk of the atypical hyperplastic cells becoming neoplastic or cancerous. Initially, the cancerous cells remain in the breast ducts, and the condition is commonly referred to as ductal carcinoma in situ (DCIS). After a time, however, the cancerous cells begin to invade outside of the ductal environment, presenting the risk of metastases, which, as is well known, can be fatal to the patient.
While breast cancer through the DCIS phase is in theory quite treatable, early diagnosis is critical to the effectiveness of the chosen treatment. At present, mammography is the most well known diagnostic tool for detecting breast cancer. However, mammography is often only able to detect tumors that have reached a size in the range from 0.1 cm to 1 cm. Such a tumor mass may not be reached until 8 to 10 years following initiation of the disease process. Detection of breast cancer at such a late stage is often too late to permit effective treatment. As a result, alternative diagnostic modalities that promise much earlier detection of breast cancer are needed.
Breast cancer is believed to originate in the lining of fluid producing breast milk ducts in the breast; and additionally human breasts are believed to contain from 6 to 8 of these ducts. See Sartorius, JAMA 224 (6): 823-827 (1973). Therefore, in a search for an answer for early detection, significant members of the medical community dedicated to studying breast cancer have believed and shown that the cytological analysis of cells retrieved from nipple discharge from the breast milk ducts can provide valuable information leading to an early identification of patients who are at risk for breast cancer. Indeed Papanicolaou contributed to the genesis of such a possibility of a xe2x80x9cPapxe2x80x9d smear for breast cancer by analyzing the cells contained in nipple discharge that collected on the outer surface of the nipple. See Papanicolaou et al, xe2x80x9cExfoliative Cytology of the Human Mammary Gland and Its Value in the Diagnosis of Cancer and Other Diseases of the Breastxe2x80x9d Cancer (1958) March/April 377-409.
Other attempts to find an early detector include Sartorious""s use of hair-like, single lumen fluid introduction catheters that were inserted into breast ducts using an operating microscope so that the ducts could be flushed with saline solution. After the fluid was introduced, the single lumen catheter was removed and the breast was squeezed so that fluid would be expelled out of the breast through the nipple. The expelled fluid typically collected on the outer surface of the nipple and was removed by a capillary tube positioned against the nipple. Similarly, Love and Barsky, xe2x80x9cBreast-duct endoscopy to study stages of cancerous breast diseasexe2x80x9d, Lancet 348 (9033):997-999, 1996 describes cannulating breast ducts with a single lumen catheter and infusing a small amount of saline, removing the catheter and squeezing to collect the fluid that returns onto the outer surface of the nipple. Additionally, in xe2x80x9cA simple method of Duct Cannulation and Localization for Galactography before Excision in Patients with Nipple Discharge.xe2x80x9d Radiology 1995; 195; 568-569 Hou et al. describes injecting a xe2x80x9csmall volume of sterile, water soluble contrast material . . . (0.5 ml-2.0 ml) . . . the catheter was taped on the breast or nipple . . . the contrast material was aspirated with the same syringe and gentle manual pressure was exerted on the breast to expel the opaque medium.xe2x80x9d
Diagnostics, Inc developed another example of a similar process for obtaining ductal fluid for cytology. This company produced devices that could be used to obtain breast ductal fluid for cytological evaluation. The devices included a hair-like single lumen breast duct catheter to infuse fluid into a breast duct and the procedure dictated that after removal of the catheter oozing fluid was collected from the nipple surface with a capillary tube. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
While the above-mentioned disclosures contemplate introducing fluid into a breast duct, they rely on externally applied pressure to expel fluid from within the duct. However, when the expelled fluids accumulate on the exterior of the nipple, it is very difficult, if not impossible, to determine the individual duct that expelled the fluid having the atypical or cancerous cells. Therefore, if the cytological examination comes back positive, it is very unlikely that the duct that produced the fluid can be identified and treated. Alternatively, in other instances, the ductal sphincter may prevent a necessary amount of ductal fluid that is needed for a useful sample from being expelled and collected. Additionally, the sphincter may block some of the cells from being passing out through the nipple.
The present invention includes devices and methods for obtaining ductal fluids and cellular material from a ductal network in a human breast in order to determine if the patient has or is likely to develop breast cancer. The devices and methods of the present invention permit the fluids and cellular material to be collected without collapsing the duct.
In a first embodiment of the present invention, the device for accessing a mammalian duct and collecting cellular material from within the duct comprises a catheter that can be positioned within the duct and a manifold lumen. The catheter includes a proximal end and a distal end. The distal end has an opening for delivering lavage fluid within the duct and receiving cellular material from within the duct. The manifold hub is in fluid communication with the catheter. The manifold hub comprises a distal end having a first port that is axially aligned with an internal lumen of the catheter, a second port positioned within the hub for infusing fluids into hub and a third port positioned within the hub for collecting fluid from within the hub.
In another aspect of the invention, the ductal access device comprises an elongated member that can be positioned within the breast duct. The elongated member comprises an internal lumen that is in fluid communication with a manifold hub.
The present invention also includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises an elongated member including a proximal end, a distal end and a lumen extending between the proximal and distal ends. The device also includes a hub comprising an infusion port for delivering fluid to the lumen of the elongated member. The infusion port is in fluid communication with an infusion device. The device further includes a collection port for receiving fluid and cellular material from within the hub.
Another aspect includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises a first elongated member having a first outer diameter for positioning within the breast duct and a second elongated member having a second outer diameter that is greater than the first outer diameter. The second outer diameter creates a stop along the length of the device that prevents the second elongated member from entering the breast duct.
The present invention also includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises a first elongated member having a proximal end, a distal end and an internal lumen extending between these ends. The device also comprises a manifold hub having a proximal end and a distal end. The manifold hub also has a lower opening that is in fluid communication with the internal lumen. An elongated guide member extends through at least one of the first elongated member and the hub for positioning a portion of the first elongated member in the breast duct.
A further aspect of the present invention includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises a first elongated member having a distal end that can move between an open position and a closed position, a proximal end and an internal lumen extending between these ends. The device also comprises a manifold hub having a proximal end and a distal end. The manifold hub also has a lower opening for being in fluid communication with the internal lumen.
A method for lavaging a ductal network in a human breast according to the present invention comprises the steps of inserting a distal end of a catheter having an internal lumen through a ductal orifice and into a distal lumen of the ductal network, infusing a lavage fluid into a manifold hub through an infusion port and introducing the lavage fluid into the ductal network. The method also includes the steps of withdrawing the lavage fluid and substances borne by the lavage fluid from the ductal network and delivering the withdrawn fluid and substances to a collection device through a collection port in the hub.
Another method for obtaining cellular material from a mammalian breast duct network according to the present invention includes the steps of inserting a distal end of an elongated device having an internal lumen through a ductal orifice and into a distal lumen of the ductal network, infusing a lavage fluid into a manifold hub through an infusion port and introducing the lavage fluid into the ductal network through the lumen. The method also includes the steps of massaging an area of the breast and delivering the lavage fluid and substances borne by the lavage fluid from the ductal network to a collection device through a collection port in the hub.
One aspect of the present invention relates to medical devices and methods for obtaining a cellular material carried by a fluid from within a breast duct so that the recovered cellular material can be analyzed for the presence of a-typical, pre-cancerous or cancerous cells. Another aspect of the present invention relates to a medical device that allows for a lavage fluid, such as saline, to be introduced into a breast duct and retrieved from the breast duct without the device being removed from the duct and without injuring the breast or the duct in which the device is positioned. A further aspect of the present invention relates to a method for safely and effectively lavaging the duct by introducing the lavage fluid into the duct, mixing the lavage fluid with cellular material within the duct and retrieving a composition of previously existing ductal fluid, at least a portion of the infused lavage fluid and the cells separated from the epithelial lining of the duct.